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British Warning on Antidepressant Use for Youth

British drug regulators yesterday recommended against the use of all but one of a new generation of antidepressants in the treatment of depressed children under 18.

In a letter sent to doctors and other health professionals, the government regulators said a review of data on the safety and effectiveness of the drugs, known as S.S.R.I.'s, indicated that their benefits did not outweigh their potential risks.

Their effectiveness in treating depression in children, they said, has not been sufficiently demonstrated, and some drugs have been linked with suicidal thoughts and self-harm in children and adolescents. A summary of the findings was published on the Web site of the British Medicines and Healthcare Products Regulatory Agency (www.mhra.gov.uk).

The agency, the equivalent of the Food and Drug Administration in the United States, said it was issuing a strong signal to doctors but was not barring the drugs completely because there were cases when their use might still be warranted.

The agency exempted Prozac, from Eli Lilly, but recommended against the use of six drugs: Paxil, from GlaxoSmithKline; Zoloft, from Pfizer; Effexor, from Wyeth; Celexa and Lexapro, from Forest Laboratories Inc., and Luvox, from Solvay.

The F.D.A. is investigating whether the data support a link between suicide and the S.S.R.I.'s -- selective serotonin reuptake inhibitors --in children and adolescents. On Feb. 2, an advisory committee for the agency will hold public hearings on the issue. But Dr. Russell Katz, director of the division of neuropharmacological drug products, said that for many reasons, finding whether such a link exists was no easy task. ''Our view at the moment is that the risk is not particularly well-understood or defined,'' Dr. Katz said. ''It is not at all a straightforward matter to figure this out.''

He said there was no indication that the British regulators had access to any studies beyond those already under review by the F.D.A.

In June, the American agency warned doctors that they should not prescribe Paxil for depressed children and adolescents until it had sorted out the issue. In October it issued a health advisory noting that doctors should use caution in prescribing S.S.R.I.'s to young patients and should closely monitor those taking the drugs.

Only a few of the drugs -- including Prozac, Paxil and Zoloft -- have been tested in large trials as a treatment for depression in young people.

One big problem for outside researchers, and for the public, is that the data that seems to show a link between the drugs and suicide is privately held by drug companies, though it has been provided to the government agencies.

Even for those who have the data, determining if a link exists is complicated, Dr. Katz and other experts said, because it is not always clear that the patients described as suicidal actually are. For example, experts say, some teenagers may cut or harm themselves but do not intend to commit suicide.

There are no reliable estimates of how many American children and teenagers are on antidepressants, but studies indicate the number has risen sharply over the past decade. Experts on the British agency's advisory committee estimated that 40,000 Britons under 18 were taking such drugs, with about half taking Prozac.

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''I think they're really overreacting,'' said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina. ''This is really going way too far, and in the process doing more harm than good.''

Dr. David Shaffer, a professor of psychiatry and pediatrics at Columbia University who sent a letter on the issue at Pfizer's request to the British drug agency, said he had concluded that there was insufficient data to restrict the use of the drugs in adolescents. ''The bottom line is that suicidal ideation and suicide attempts are very common in depressed kids,'' he said.

Dr. David Healy, of the University of Wales College of Medicine, who has been outspoken about the need for more unbiased testing of antidepressants, said the British agency had not addressed larger questions about the drugs.

''The issue isn't necessarily that these drugs should be banned for children,'' he said. ''The question is, 'What is the safest way they can be used?' ''

Other researchers said the British action was helpful in calling attention to the unanswered questions about the effectiveness and safety of antidepressants for children.

''Right now there is a large question of whether the standard of treatment for children diagnosed with depression'' should be the inhibitors, said Dr. Julie Magno Zito, associate professor of pharmacy and medicine at the University of Maryland.

Alison Langley, a spokeswoman for the British agency, said the recommendation was issued because the drugs ''don't work in the majority of cases for children under 18 with depressive illnesses.''

Although the regulators cautioned doctors that the S.S.R.I.'s should not be prescribed ''as new therapy,'' they added that if a child was already taking one of the drugs and doing well, ''the normal completion of the planned treatment course should be considered as an option in the management of the illness.''

They also said that the drugs might still be appropriate for some children -- those who cannot tolerate Prozac, for example -- and cautioned only that in such cases the medication should be prescribed and supervised by a specialist rather than by a general practitioner.

In addition, the regulators noted that their recommendation did not apply to the use of Luvox and Zoloft for children and adolescents who suffered from obsessive-compulsive disorder, citing research that demonstrated the effectiveness of the two drugs for the condition.

Children and adolescents who are currently taking the drugs, the regulators cautioned, should not stop taking them abruptly or change their treatment without medical supervision.

Correction: December 17, 2003, Wednesday A front-page article on Thursday about British regulators' warnings against prescribing certain antidepressants for children misstated the class of chemical compound to which one drug belonged. Effexor, made by Wyeth, is a selective serotonin and norepinephrine reuptake inhibitor, or S.N.R.I. (not a selective serotonin reuptake inhibitor, or S.S.R.I.).